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INTERVIEW: EU industry calls for specialized, not special, notified bodies

This article was originally published in Clinica

Executive Summary

The EU medtech industry is calling for notified bodies who audit innovative and high-risk devices to specialize in specific medical domains, a measure that goes beyond what have been proposed so far by either the European Commission or Parliament. This specialization would address the demands of a sector that spans a wide range of technologies used in a broad scope of medical applications and carry a variety of potential risks.

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